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FDA lays out proposal for once-a-year COVID booster shots

FILE — Finley Martin, 14, gets a shot of the Pfizer COVID-19 vaccine at the First Baptist Church of Pasadena, May 14, 2021, in Pasadena, Calif. (AP Photo/Marcio Jose Sanchez, File)
FILE — Finley Martin, 14, gets a shot of the Pfizer COVID-19 vaccine at the First Baptist Church of Pasadena, May 14, 2021, in Pasadena, Calif. (AP Photo/Marcio Jose Sanchez, File)
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Americans could soon be able to get an annual coronavirus booster like the annual push to get people flu shots if the Food and Drug Administration approves a plan proposed by the agency on Monday.

Under the FDA proposal, most adults and children would be able to get a shot once a year to protect them against the virus that epidemiologists expect to linger and mutate for years to come.

The proposal is a push to simplify the COVID vaccination process, which has received some criticism for being too confusing and difficult for people to track if they are up to date on their inoculations.

“This reflects some very pragmatic thinking on the part of the FDA and trying to determine how to best use these very effective vaccines in the future,” said Dr. Matthew Laurens, professor of pediatrics and medicine at the University of Maryland School of Medicine. “Knowing that the virus is likely to mutate, and that transmission was going to continue — it's not going to stop anytime soon — so how do we best use these vaccines to protect the most people we can in the population?”

The proposal comes as people continue to return to pre-pandemic norms with travel, daily life and spending time in public, crowded places. Health officials have been urging people to practice caution since cooler weather began to set in during the fall along with a wave of COVID, flu and RSV cases.

Part of that push is getting more people to receive the vaccine, which has not gone as well as the pandemic has gone on.

Americans have been less likely to get vaccinated with every round that has been released, according to data from the Centers for Disease Control and Prevention. Eighty-one percent of the U.S. population has received at least one dose of the primary series of shots, including 95% of those 65 and older, who are at the highest risk of severe illness and death.

Since the bivalent booster was released last fall, only 15.3% of Americans have received the shot. Nearly 40% of the population 65 and up have gotten a bivalent booster.

Overcoming vaccine hesitancy and informing Americans that new rounds of shots are approved and available has been an issue for U.S. public health agencies. While there is some optimism that combining visits for a flu and COVID shot may help ease some concerns, it’s not clear how effective it will be.

“While this creates a more streamlined approach it still fails to address the reasons for vaccine hesitancy, and I believe the lack of unity even within the medical community on whether this is needed will not help to increase trust in the new vaccines,” said Amber Reinhart, an associate professor of communication at the University of Missouri-St. Louis who studies health communications. “Limited data on the bivalent rollout demonstrated it was not as effective as originally anticipated and I believe this limited some people from thinking anything beyond the initial shots were required.”

Health officials have said the most important groups to receive vaccinations are those at the highest risk of severe disease and death: older adults, pregnant women, people who are immunocompromised and those with other underlying conditions that heighten their risk of severe illness.

The FDA’s advisory panel made of outside vaccine experts will meet with the agency on Thursday, where they will be asked to vote on the once-a-year proposal as well as if all vaccines should target the same strains.

If the proposal were to be approved, vaccine manufacturers, the FDA and independent experts would decide what strains to target each year. Manufacturers would then update the annual shot and produce them to launch in the fall, similar to the approach used for flu shots that the private industry has experience handling, and the public is more aware of.

Doctors are hoping an easier schedule and regimen will help persuade more people to roll up their sleeves.

“A much more straightforward schedule will make the dosing regimens much more easy to both administer and to anticipate so I think it would simplify everything on all fronts in terms of manufacturing in terms of vaccine delivery, storage, the perception and the public,” Laurens said.

But there is still some debate among as to whether moving to make COVID vaccines an annual experience due to a lack of data on its usefulness among young and otherwise healthy people, which could add some issues with achieving a smooth and effective rollout.

“I think it is a disservice to the previous approach of letting the data lead us to our next steps to now switch and instead develop protocols that aren’t backed by scientific data,” Reinhart said. “I understand the desire for something more simplistic, like the annual flu shot, but I think it is important to weigh the risks with the benefits and be able to clearly answer the question of whether this is needed for those who are not in a high-risk category. Right now there isn’t enough data out there to make that call. “

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